Effect of Buglossoides Oil on Recent Chronic Non-injurious Hip and Knee Pain

NCT03576625 | Unknown Phase 1

• 1 other identifier: HC-NNHPD-230190
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

The effect of Buglossoides oil emulsion on the intensity of recent chronic knee and hip pain, on plasma and mononuclear blood cells fatty acid profiles and on whole blood Eicosapentaenoic acid production will be investigated.

Conditions

Hip Pain Chronic; Knee Pain Chronic

Keywords

Buglossoides arvensis; vegetable oil; omega-3 fatty acids; participants

Outcome Measures

Primary Outcomes (2)

• Change in the nature of pain severity

  Defined by visual analogue scale (VAS)

  Baseline, 19, 38, 56 days

• Change in the nature of fatigue severity

  Defined by visual analogue scale (VAS)

  Baseline, 19, 38, 56 days

Secondary Outcomes (8)

• Nature and frequency of analgesic use

  56 days

• Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain, stiffness and physical function scores

  Baseline, 19, 38, 56 days

• Plasma eicosapentaenoic concentration (EPA)

  Baseline and day 56

• Plasma 20:4n-3

  Baseline and day 56

• Plasma docosapentaenoic acid

  Baseline and day 56

Study Arms (2)

High oleic sunflower oil (HOSO)

PLACEBO COMPARATOR

30 ml HOSO emulsion (equivalent to 9.9 ml oil) in a single dose, 56 days

Dietary Supplement: High Oleic Sunflower Oil

Buglossoides oil emulsion

EXPERIMENTAL

30 ml Buglossoides oil emulsion (equivalent to 9.9 ml oil) in a single dose, 56 days

Dietary Supplement: Buglossoides Oil

Interventions

High Oleic Sunflower Oil DIETARY_SUPPLEMENT

Consume oil smoothie (emulsified HOSO) with a meal once daily for 9 weeks

Also known as: HOSO

High oleic sunflower oil (HOSO)

Buglossoides Oil DIETARY_SUPPLEMENT

Consume oil smoothie (emulsified Buglossoides oil) with a meal once daily for 9 weeks

Also known as: Ahiflower

Buglossoides oil emulsion

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men or non-pregnant women, using an effective form of birth control (such as oral contraceptives, injectable contraceptives or the barrier method such as a intrauterine device (IUD) with a spermicide, a diaphragm with a spermicide, a condom with a spermicide or a sponge with a spermicide) for at least 3 months prior to entry into the study and continuing during participation in the study.
• to 65 years of age, inclusive.
• Body mass index (BMI) 18 - 39.9 kg/m2
• Subject has recent (less than 6 months) current chronic (having lasted more than two weeks) knee (one or both) and/or hip pain that is not the result of an acute injury. Pain intensity is 20 mm or higher using a Visual Analog Scale ranging from 0-100 mm.
• Subject has no planned knee or hip surgery.
• Subject is willing to avoid alcohol consumption for 24h prior to every clinic visit.
• The subject will not modify smoking habits during supplementation period.
• No significant medical conditions that in the opinion of the qualified physician, would preclude the subject's participation in the study.
• Signed informed consent.
• Willing to follow all study procedures including study visits, fasting blood draws, stable body weight, normal eating habits, current activity level, and compliance with study preparation.
• Willing to not consume fish, crustaceans and shellfish for the duration of the study.
• Willing to avoid taking anti-inflammatory medications (analgesics and NSAIDs) for 24 hours prior to Visits 2 and 5.

You may not qualify if:

• Pregnancy or lactation. Women trying to conceive. Women who will try to conceive who are unwilling to commit to the use of a medically approved form of contraception throughout the study period. Method of contraception must be recorded in the case report file.
• Has had a diagnosis of rheumatoid arthritis.
• Individual has a condition the study physician believes would interfere with the participant's ability to provide informed consent, comply with his responsibilities during the study, which might confound the interpretation of the study results or put the person at undue risk.
• Self-reported medical conditions including an active peptic ulcer, inflammatory bowel disease, or gastrointestinal bleeding and any medical condition or prior gastrointestinal surgery that could influence absorption, metabolism or excretion of the study supplement.
• History or presence of significant, renal, hepatic, gastrointestinal, pulmonary, biliary, neurological or endocrine disorders.
• History or presence of cancer in the past 2 yrs, except for non-melanoma skin cancers (e.g. basal or squamous cell carcinoma of the skin).
• Clinically significant abnormal laboratory test results including but not limited to LDL-cholesterol ≥ 4.1mM, triglyceride levels ≥3.95mM, fasting creatinine ≥ 1.5 mg/dL, ALT or AST ≥ 1.5X the upper limit of normal.
• Currently being treated for angina, arrhythmia and/or congestive heart failure. History of myocardial infarction or stroke.
• Uncontrolled hypertension (resting systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg).
• Type 1 or 2 diabetes. Fasting glucose ≥ 100 mg/dL. HbA1c ≥ 6.0.
• If a smoker, subject smokes no more than 1 pack (20 cigarettes) daily.
• History (within 12 months) or current alcohol or substance abuse (no more than 14 consumptions per week; 1 consumption= 12 oz beer, 5 oz wine, 1.5 oz distilled spirits).
• Use of steroidal anti-inflammatory medications (prednisone, etc)
• Use of any lipid-altering medications (statins, bile acid sequestrants, cholesterol absorption inhibitors, fibrates, prescription formulations of niacin).
• Use of any weight loss or lipid metabolism medication/supplement/program (including lipase inhibitors) within 1 month of study period OR weight gain or loss \> 2 kg in the past 3 months.

Sponsors & Collaborators

• Réseau de Santé Vitalité Health Network: lead

Study Sites (1)

Université de Moncton

Moncton, New Brunswick, E1A3E9, Canada

RECRUITING

Study Officials

• Marc Surette, PhD

  Université de Moncton, Moncton, NB, Canada

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marc Surette, PhD

CONTACT

1-506-858-4293; marc.surette@umoncton.ca

Patrick-Denis St-Coeur, MSc

CONTACT

1-506-858-4139; patrick-denis.st-coeur@umoncton.ca

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2018
• First Posted: July 3, 2018
• Study Start: February 10, 2018
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: July 3, 2018

Record last verified: 2017-09

Locations

CA (1)